Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
NCT ID: NCT00039130
Last Updated: 2023-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2002-05-31
2014-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
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Detailed Description
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* Determine the complete response rate in patients with previously untreated Burkitt's lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy with filgrastim (G-CSF) support.
* Determine the progression-free and overall survival of patients treated with this regimen.
* Determine the feasibility and toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma).
* Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.
* Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4 and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2, patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4 and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood counts recover.
* Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5; oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and 6. After course 3, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab with High Intensity Chemotherapy
Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6) Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)
filgrastim
5 ug/kg/day sub Q injection day 7 until ANC\>5000/ul courses II-VII
rituximab
Day 8 course II 50 mg/sq m IV infusion: d 8 course IV \& VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
cyclophosphamide
200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
cytarabine
1 g/sq m/day IV infusion Days 4 \& 5, courses II, IV, VI
dexamethasone
10mg/sq m PO or IV Days 1-5 courses II-VII
doxorubicin hydrochloride
25 mg/sq m/day IV infusion Days 4 \& 5 courses III,V, VII
etoposide
80 mg/sq m/day IV infusion Days 4 \& 5 courses II, IV, VI
ifosfamide
800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
leucovorin calcium
25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX \<10nM, courses II-VII
methotrexate
1.5 g/sq m IV infusion Day 1 courses II-VII
prednisone
60 mg/sq m PO/day Days 1-7 course I
vincristine sulfate
2 mg IV push Day 1 courses II-VII
Allopurinol
300 mg/day PO Days 1-14, course I
Interventions
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filgrastim
5 ug/kg/day sub Q injection day 7 until ANC\>5000/ul courses II-VII
rituximab
Day 8 course II 50 mg/sq m IV infusion: d 8 course IV \& VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
cyclophosphamide
200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
cytarabine
1 g/sq m/day IV infusion Days 4 \& 5, courses II, IV, VI
dexamethasone
10mg/sq m PO or IV Days 1-5 courses II-VII
doxorubicin hydrochloride
25 mg/sq m/day IV infusion Days 4 \& 5 courses III,V, VII
etoposide
80 mg/sq m/day IV infusion Days 4 \& 5 courses II, IV, VI
ifosfamide
800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
leucovorin calcium
25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX \<10nM, courses II-VII
methotrexate
1.5 g/sq m IV infusion Day 1 courses II-VII
prednisone
60 mg/sq m PO/day Days 1-7 course I
vincristine sulfate
2 mg IV push Day 1 courses II-VII
Allopurinol
300 mg/day PO Days 1-14, course I
Eligibility Criteria
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Inclusion Criteria
* Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or Burkitt's or Burkitt-like lymphoma
* L3 morphology surface IgG expression
* Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)
* Previously untreated disease except hydroxyurea for leukocytosis
* CNS involvement allowed
* Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement must also be enrolled on CALGB-8461
* Patients with Burkitt's leukemia must also be enrolled on CALGB-9665
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent interleukin-11
Chemotherapy:
* See Disease Characteristics
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes)
* No concurrent steroids except for adrenal failure
Radiotherapy:
* No concurrent palliative radiotherapy except whole-brain irradiation for documented CNS disease
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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David Rizzieri, MD
Role: STUDY_CHAIR
Duke University Medical Center Bone Marrow Transplant
Locations
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Naval Medical Center - San Diego
San Diego, California, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Rizzieri DA, Johnson JL, Byrd JC, Lozanski G, Blum KA, Powell BL, Shea TC, Nattam S, Hoke E, Cheson BD, Larson RA; Alliance for Clinical Trials In Oncology (ACTION). Improved efficacy using rituximab and brief duration, high intensity chemotherapy with filgrastim support for Burkitt or aggressive lymphomas: cancer and Leukemia Group B study 10 002. Br J Haematol. 2014 Apr;165(1):102-11. doi: 10.1111/bjh.12736. Epub 2014 Jan 15.
Other Identifiers
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CALGB-10002
Identifier Type: -
Identifier Source: secondary_id
CDR0000069354
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-10002
Identifier Type: -
Identifier Source: org_study_id
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